Vascular filters, deflectors, and methods

ABSTRACT

Vascular filters and deflectors and methods for filtering bodily fluids. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.

INCORPORATION BY REFERENCE

This application is a divisional of U.S. patent application Ser. No.14/693,763, filed on Apr. 22, 2015, which is hereby incorporated byreference in its entirety for all purposes.

BACKGROUND

Field

The disclosure relates to devices and methods for filtering body fluidssuch as blood and/or selectively deflecting potentially embolicparticles from the body fluid. The devices can be catheter-based forinsertion into a vascular system of a subject.

Description of Related Art

Thromboembolic disorders, such as stroke, pulmonary embolism, peripheralthrombosis, atherosclerosis, and the like affect many people. Thesedisorders are a major cause of morbidity and mortality in the UnitedStates and throughout the world. Thromboembolic events are characterizedby an occlusion of a blood vessel. The occlusion can be caused by a clotwhich is viscoelastic (jelly-like) and comprises platelets, fibrinogen,and other clotting proteins.

Percutaneous aortic valve replacement procedures have become popular,but stroke rates related to this procedure are between four and twentypercent. During catheter delivery and valve implantation, plaque orother material may be dislodged from the vasculature and may travelthrough the carotid circulation and into the brain. When an artery isoccluded by a clot or other embolic material, tissue ischemia (lack ofoxygen and nutrients) develops. The ischemia progresses to tissueinfarction (cell death) if the occlusion persists. Infarction does notdevelop or is greatly limited if the flow of blood is reestablishedrapidly. Failure to reestablish blood-flow can lead to the loss of limb,angina pectoris, myocardial infarction, stroke, or even death.

Reestablishing blood flow and removal of the thrombus is highlydesirable. Surgical techniques and medicaments to remove or dissolveobstructing material have been developed, but exposing a subject tosurgery may be traumatic and is best avoided when possible.Additionally, the use of certain devices carry risks such as the risk ofdislodging foreign bodies, damaging the interior lining of the vessel asthe catheter is being manipulated, blood thinning, etc.

SUMMARY

Vascular filters and deflectors and methods for filtering bodily fluidsare disclosed herein. A blood filtering assembly can capture embolicmaterial dislodged or generated during an endovascular procedure toinhibit or prevent the material from entering the cerebral vasculature.A blood deflecting assembly can deflect embolic material dislodged orgenerated during an endovascular procedure to inhibit or prevent thematerial from entering the cerebral vasculature.

In some embodiments, a method of inhibiting embolic material fromentering cerebral vasculature comprises positioning a guidewire in aleft subclavian artery upstream of a left vertebral artery and trackinga distal portion of a protection device over the guidewire. The distalportion of the protection device comprises an outer sheath, an innermember radially inward of the outer sheath, and a self-expanding filterassembly radially between the outer sheath and the inner member. Theinner member comprises a guidewire lumen. The method further comprisesat least one of proximally retracting the outer sheath and distallyadvancing the self-expanding filter assembly to deploy theself-expanding filter assembly from the outer sheath in the leftsubclavian artery upstream of the left vertebral artery. The method mayfurther comprise performing an endovascular procedure. The endovascularprocedure may comprise mitral or atrial valve implantation orreplacement. The deployed self-expanding filter assembly may inhibitembolic material from entering cerebral vasculature through the leftvertebral artery during the endovascular procedure. The method mayfurther comprise, after performing the endovascular procedure,withdrawing the self-expanding filter assembly from the left subclavianartery.

After deploying the self-expanding filter assembly, the inner member mayprolapse into an aortic arch. The method may further comprise proximallyretracting the inner member out of the aortic arch while the deployedself-expanding filter assembly remains in the left subclavian arteryupstream of the left vertebral artery. The method may further comprisemonitoring arterial pressure using the outer sheath. The method mayfurther comprise providing fluid through the outer sheath. The methodmay further comprise positioning a filtering device in an innominateartery and a left common carotid artery. The filtering device mayinhibit embolic material from entering cerebral vasculature through aright vertebral artery, a right common carotid artery, and the leftcommon carotid artery during the endovascular procedure.

In some embodiments, a method of inhibiting embolic material fromentering cerebral vasculature comprises positioning a distal portion ofa protection device at a location. The location is in the leftsubclavian artery and/or the left vertebral artery. The distal portionof the protection device comprises an outer sheath and at least one of aself-expanding filter assembly and a self-expanding deflector assemblyradially inward of the outer sheath. The method further comprisesdeploying the at least one of a self-expanding filter assembly and aself-expanding deflector assembly from the outer sheath at the location.The deployed self-expanding filter assembly and/or self-expandingdeflector assembly inhibits embolic material from entering cerebralvasculature during an endovascular procedure.

The distal portion of the protection device may further comprise aninner member radially inward of the outer sheath. The inner member maycomprise a guidewire lumen. Positioning the distal portion of theprotection device at the location may comprise tracking the distalportion of the protection device over a guidewire. The method mayfurther comprise monitoring arterial pressure using at least one of theinner member and the outer sheath. The distal portion of the protectiondevice may comprise the self-expanding filter assembly. The distalportion of the protection device may comprise the self-expandingdeflector assembly. The endovascular procedure may comprise atrial valveor mitral valve implantation or replacement. Deploying the at least oneof a self-expanding filter assembly and a self-expanding deflectorassembly may comprise proximally retracting the outer sheath. Afterdeploying the at least one of a self-expanding filter assembly and aself-expanding deflector assembly, the inner member may prolapse into anaortic arch, and the method may further comprise proximally retractingthe inner member out of the aortic arch while the deployed at least oneof a self-expanding filter assembly and a self-expanding deflectorassembly remains in the location. The method may further comprisepositioning a filtering device in an innominate artery and a left commoncarotid artery. The filtering device may inhibit embolic material fromentering cerebral vasculature through a right vertebral artery, a rightcommon carotid artery, and the left common carotid artery during theendovascular procedure.

In some embodiments, an embolic material protection device configured toinhibit embolic material from entering cerebral vasculature through aleft vertebral artery comprises an outer sheath, an inner memberradially inward of the outer sheath, and a self-expanding filterassembly radially between the outer sheath and the inner member. Theinner member comprises a lumen. The self-expanding filter assembly isdeployable out of the outer sheath by at least one of proximallyretracting the outer sheath and distally advancing the self-expandingfilter assembly. The inner member may be longitudinally movableindependent of the self-expanding filter assembly and the outer sheath.

The self-expanding filter assembly may have a diameter between 7 mm and12 mm. The self-expanding filter assembly may have a diameter between 2mm and 4.5 mm. The device may further comprise an arterial pressuremonitoring device in fluid communication with the lumen of the outersheath. A kit may comprising the device of and a filtering deviceconfigured to be positioned in an innominate artery and a left commoncarotid artery.

In some embodiments, an embolic material protection device configured toinhibit embolic material from entering cerebral vasculature through aleft vertebral artery comprises an outer sheath and a deflectorassembly. The deflector assembly may be deployable out of the outersheath by at least one of proximally retracting the outer sheath anddistally advancing the deflector assembly. The device may furthercomprise an inner member. The inner member may comprise a lumen. Thedeflector assembly may comprise a surface configured to be placed acrossan ostium of an artery. The deflector assembly may be coupled to adistal end of the outer sheath and a distal end of the inner member, andmay comprise a frustoconical shape upon manipulation of at least one ofthe outer sheath and the inner member. The deflector assembly maycomprise an at least partially arcuate surface configured to be placedacross an ostium of the left vertebral artery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic perspective view of an aortic arch.

FIG. 2 illustrates an example protection device.

FIG. 2A is a cross-sectional view of the protection device of FIG. 2taken along the line 2A-2A in FIG. 2.

FIG. 3 is a side cross-sectional view of an example proximal portion ofa protection device.

FIG. 4A illustrates an example distal portion of a protection device ina delivery state.

FIG. 4B illustrates the example distal portion of FIG. 4A in a deployedstate.

FIG. 4C is a cross-sectional view of the distal portion of FIGS. 4A and4B along the line 4C-4C of FIG. 4B.

FIG. 4D is an enlarged view of part of the distal portion of FIGS. 4Aand 4B.

FIG. 5A illustrates an example guidewire loading tool.

FIG. 5B illustrates an example coupling system.

FIG. 5C illustrates another example coupling system.

FIG. 5D illustrates an example inner member manipulation tool.

FIG. 5E illustrates an example coupling system.

FIG. 5F illustrates another example coupling system.

FIG. 5G illustrates yet another example coupling system.

FIG. 5H illustrates still another example coupling system.

FIG. 5I illustrates yet still another example coupling system.

FIGS. 6A and 6B illustrate method of using an example distal portion ofa protection device in a deployed state in target vasculature.

FIG. 7 illustrates an example distal portion of a protection device in adeployed state in vasculature in combination with a second protectiondevice.

FIG. 8 illustrates an example distal portion of a protection device in adeployed state.

FIG. 9A illustrates the example distal portion of FIG. 9A in a deliverystate in vasculature.

FIG. 9B illustrates the example distal portion of FIG. 9A in a deployedstate in the vasculature.

FIG. 10 illustrates another example distal portion of a protectiondevice in a deployed state in vasculature in combination with a secondprotection device.

FIG. 11 illustrates another example distal portion of a protectiondevice in a deployed state in vasculature.

FIG. 12A illustrates an example protection device.

FIG. 12B illustrates another example protection device.

FIGS. 13A-13D illustrate another example protection device.

FIGS. 13E and 13F are cross-sectional views of the example protectiondevice of FIGS. 13A-13D.

FIG. 14 illustrates another example distal portion of a protectiondevice in a deployed state in vasculature.

FIGS. 15A-15D illustrate another example protection device.

FIG. 16A illustrates another example distal portion of a protectiondevice in a deployed state in vasculature.

FIG. 16B is a cross-sectional view of the example distal portion of theprotection device and the vasculature of FIG. 16A along the line 16B-16Bof FIG. 16A.

FIG. 17 illustrates another example distal portion of a protectiondevice in a deployed state in vasculature.

DETAILED DESCRIPTION

The disclosure generally relates to devices and methods for filteringfluids and/or deflecting debris contained within fluids, including bodyfluids such as blood. A filtering or deflecting device can be positionedin an artery before and/or during an endovascular procedure (e.g.,transcatheter aortic valve implantation (TAVI) or replacement (TAVR),transcatheter mitral valve implantation (TAMI) or replacement (TAMR),surgical aortic valve replacement (SAVR), other surgical valve repair,implantation, or replacement, cardiac ablation (e.g., ablation of thepulmonary vein to treat atrial fibrillation) using a variety of energymodalities (e.g., radio frequency (RF), energy, cryo, microwave,ultrasound), cardiac bypass surgery (e.g., open-heart, percutaneous),transthoracic graft placement around the aortic arch, valvuloplasty,etc.) to inhibit or prevent embolic material such as debris, emboli,thrombi, etc. resulting from entering the cerebral vasculature.

The devices may be used to trap particles in other blood vessels withina subject, and they can also be used outside of the vasculature. Thedevices described herein are generally adapted to be deliveredpercutaneously to a target location within a subject, but can bedelivered in any suitable way and need not be limited tominimally-invasive procedures.

FIG. 1 is a schematic perspective view of an aortic arch 10. The aorticarch 10 is upstream of the left and right coronary arteries. The aorticarch 10 typically includes three great branch arteries: thebrachiocephalic artery or innominate artery 12, the left common carotidartery 14, and the left subclavian artery 16. The innominate artery 12branches to the right carotid artery 18, then the right vertebral artery20, and thereafter is the right subclavian artery 22. The rightsubclavian artery 22 supplies blood to, and may be directly accessedfrom (termed right radial access), the right arm. The left subclavianartery 16 branches to the left vertebral artery 24, usually in theshoulder area. The left subclavian artery 16 supplies blood to, and maybe directly accessed from (termed left radial access), the left arm.Four of the arteries illustrated in FIG. 1 supply blood to the cerebralvasculature: (1) the left carotid artery 14 (about 40% of cerebral bloodsupply); (2) the right carotid artery 18 (about 40% of cerebral bloodsupply); (3) the right vertebral artery 20 (about 10% of cerebral bloodsupply); and (4) the left vertebral artery 24 (about 10% of cerebralblood supply). The devices and methods described herein are alsocompatible with the prevalent (27%) bovine variant.

Devices and methods, some of which are compatible and/or synergisticwith the devices and methods described herein, have been developed tofilter blood flowing to the innominate artery 12 and the left commoncarotid artery 14, which provide about 90% of the blood entering thecerebral vasculature. Examples are provided in U.S. Pat. No. 8,876,796,which is incorporated herein by reference in its entirety, and mostparticularly with respect to disclosure directed to devices and methodsfor protecting aortic arch branch arteries and structures of filterdevices. Certain such devices and methods leave the left subclavianartery 16, and thus the left vertebral artery 24, which provides about10% of the blood entering the cerebral vasculature, exposed to potentialembolic material. Other embodiments described in U.S. Pat. No. 8,876,796filter blood flowing to the left common carotid artery 14 and the leftsubclavian artery 16. Certain such devices and methods leave theinnominate artery 12, and thus both the right common carotid artery 18and the right vertebral artery 20, which provide even about 50% of theblood entering the cerebral vasculature, exposed to potential embolicmaterial. Assuming perfect use and operation, either of these optionsmay leave potential stroke rates as high as two to ten percent due toexposed arteries that provide blood flow to the cerebral vasculature.

FIG. 2 illustrates an example protection device 200. The protectiondevice 200 can inhibit or prevent embolic material from entering thecerebral vasculature by protecting a cerebral artery (e.g., the leftvertebral artery) during an endovascular procedure. Protection of theleft vertebral artery using the protection device 200 can reduce therisk of stroke in procedures with no other embolic protection by about10%. Protection of the left vertebral artery using the protection device200 (e.g., in the left subclavian artery or the left vertebral artery)can reduce the risk of stroke in procedures with another embolicprotection such as described in U.S. Pat. No. 8,876,796 positioned inthe innominate artery and the left common carotid artery to less thanabout 5%, less than about 3%, less than about 1%, or almost nil.Protection of the innominate artery using the protection device 200 canreduce the risk of stroke in procedures with no other embolic protectionby about 50%. Protection of the innominate artery using the protectiondevice 200 can reduce the risk of stroke in procedures with anotherembolic protection such as described in U.S. Pat. No. 8,876,796positioned in the left common carotid artery and the left subclavianartery to less than about 5%, less than about 3%, less than about 1%, oralmost nil.

The protection device 200 comprises a proximal portion 202 and a distalportion 204. The proximal portion 202 is configured to be held andmanipulated by a user such as a surgeon. The distal portion 204 isconfigured to be positioned at a target location such as the leftsubclavian artery or the left vertebral artery. The location ispreferably proximate to the ostium of the artery. When the distalportion 204 is configured to be positioned at the left subclavianartery, the location is preferably upstream of the left vertebralartery.

The proximal portion 202 comprises a handle 206, a control 208 such as aslider, an outer sheath 210, a port 212, optionally an inner membertranslation control 214 such as a knob, and optionally a hemostasisvalve control 216 such as a knob. Although not visible in FIG. 2, theproximal portion 202 also comprises an inner member 220 radially inwardof the outer sheath 210. Although not visible in FIG. 2, the proximalportion 202 also comprises a filter wire 217 (FIG. 2A) radially inwardof the outer sheath 210. The filter wire 217 is coupled to the filterassembly 218 in the distal portion 204. The outer sheath 210 may have adiameter between about 4 French (Fr) (approximately 1.33 millimeters(mm)) and about 6 Fr (approximately 2 mm) (e.g., about 5 Fr(approximately 1.67 mm)). The outer sheath 210 may comprise anatraumatic distal tip. Other features of the protection device 200 andother protection devices described herein may be flexible and/oratraumatic. The outer sheath 210 may comprise a curvature, for examplebased on an intended placement location (e.g., the left subclavianartery and/or the left vertebral artery).

The slider 208 can be used to translate the outer sheath 210 and/or afilter assembly 218 (e.g., coupled to a filter wire). For example, theslider 208 may proximally retract the outer sheath 210, the slider 208may distally advance the filter assembly 218 out of the outer sheath210, or the slider 208 may proximally retract the outer sheath 210 anddistally advance the filter assembly 218 (e.g., simultaneously orserially), which can allow the filter assembly 218 to radially expand.The slider 208 may also be configured to have an opposite translationeffect, which can allow the filter assembly 218 to be radially collapsed(e.g., due to compression by the outer sheath 210) as the filterassembly 218 is drawn into the outer sheath 210. Other deploymentsystems are also possible, for example comprising gears or otherfeatures such as helical tracks (e.g., configured to compensate for anydifferential lengthening due to foreshortening of the filter assembly218, configured to convert rotational motion into longitudinal motion),a mechanical element, a pneumatic element, a hydraulic element, etc. foropening and/or closing the filter assembly 218.

The port 212 is in fluid communication with the inner member 220 (e.g.,via a Y-shaped connector in the handle 206). The port 212 can be used toflush the device (e.g., with saline) before, during, and/or after use,for example to remove air. The port 212 can also or alternatively beused to monitor blood pressure at the target location, for example byconnecting an arterial pressure monitoring device in fluid communicationwith a lumen 221 (FIG. 2A) of the outer sheath 210. The port 212 can bealso or alternatively be used to inject contrast agent, dye,thrombolytic agents such as tissue plasminogen activator (t-PA), etc.The slider 208 preferably does not interact with the inner member 220such that the inner member 220 is longitudinally movable independent ofthe filter assembly 218 and the outer sheath 210. The inner membertranslation control 214 can be used to longitudinally translate theinner member 220, for example before, after, and/or during deployment ofthe filter assembly 218. The inner member translation control 214 maycomprise a slider in the housing 206 (e.g., separate from the slider208).

The rotatable hemostasis valve control 216 can be used to reduce orminimize fluid loss through the protection device 200 during use. Forexample, when positioned in the left subclavian artery, the direction ofblood flow with respect to the device 200 will be distal to proximal, soblood may be otherwise inclined to follow the pressure drop out of thedevice 200. The hemostasis valve control 216 is illustrated as beingrotatable, but other arrangements are also possible (e.g.,longitudinally displaceable). The hemostasis valve control 216 may beconfigured to fix relative positions of the outer sheath 210 and thefilter assembly 218, for example as described with respect to thehemostasis valve in U.S. Pat. No. 8,876,796. The hemostasis valve 216may comprise, for example, an elastomeric seal and HV nut.

The distal portion 204 comprises the outer sheath 210, a filter assembly218 radially inward of the outer sheath 210, and optionally the innermember 220. The filter assembly 218 may be radially between the outersheath 210 and the inner member 220 (e.g., radially inward of the outersheath 210 and the inner member 220 radially inward of the filterassembly 218) in a delivery state or shape or position.

The filter assembly 218 may comprise a self-expanding filter assembly(e.g., comprising a superelastic material with stress-induced martensitedue to confinement in the outer sheath 210). The filter assembly 218 maycomprise a shape-memory material configured to self-expand upon atemperature change (e.g., heating to body temperature). The filterassembly 218 may comprise a shape-memory or superelastic frame (e.g.,comprising a distal end hoop comprising nitinol) and a microporousmaterial (e.g., comprising a polymer including laser-drilled holes)coupled to the frame, for example similar to the filter assembliesdescribed in U.S. Pat. No. 8,876,796.

The filter assembly 218 may be coupled (e.g., crimped, welded, soldered,etc.) to a distal end of a deployment wire or filter wire 217. Thefilter wire 217 can comprise a rectangular ribbon, a round (e.g.,circular, elliptical) filament, a portion of a hypotube, a braidedstructure (e.g., as described herein), combinations thereof, and thelike. The filter wire 217 can be coupled to the handle 206 and/or theslider 208 to provide differential longitudinal movement versus theouter sheath 210, as shown by the arrows 222, which can sheathe andunsheathe the filter assembly 218 from the outer sheath 210.

FIG. 2A is a cross-sectional view of the protection device 200 of FIG. 2taken along the line 2A-2A in FIG. 2. The inner member 220 is in thelumen 211 of the outer sheath 210. The inner member 220 may be coaxialwith the outer sheath 210. The guidewire 226 is in the lumen 221 of theinner member 220. The guide wire 226 may be coaxial with the innermember 220. The filter wire 217 is also in the outer sheath 210, forexample to one side of the inner member 220. In implementations in whichthe filter wire 217 comprises a deployment tube (e.g., as describedherein), the deployment tube may be coaxial with and radially betweenthe outer sheath 210 and the inner member 220.

The filter assembly 218 in an expanded, unconstrained state has amaximum diameter or effective diameter (e.g., if the mouth is in theshape of an ellipse) d. The diameter d can be between about 1 mm andabout 15 mm (e.g., at least about 1 mm, about 2 mm, about 3 mm, about 4mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm,ranges between such values, etc.). In some embodiments (e.g., when thefilter assembly is configured to be positioned in the left subclavianartery), the diameter d is between about 7 mm and about 12 mm (e.g.,about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12mm, ranges between such values, etc.). In some embodiments (e.g., whenthe filter assembly is configured to be positioned in the left vertebralartery), the diameter d is between about 2 mm and about 4.5 mm (e.g.,about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about4.5 mm, ranges between such values, etc.). Other diameters d or othertypes of lateral dimensions are also possible. Different diameters d canallow treatment of a selection of subjects having different vesselsizes.

The filter assembly 218 has a maximum length l. The length l can bebetween about 7 mm and about 50 mm (e.g., at least about 7 mm, about 8mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm,about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm,about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about50 mm, ranges between such values, etc.). Other lengths l are alsopossible, for example based on the diameter or effective diameter d. Forexample, the length l of the filter assembly 218 may increase as thediameter d increases, and the length l of the filter assembly 218 maydecrease as the diameter d decreases. A distance from an apex of themouth of the filter assembly 218 to an elbow in the frame may be about35 mm. Different lengths l can allow treatment of a selection ofsubjects having different vessel sizes.

The inner member 220 is optional, but can provide additional uses and/oradvantages in combination with the filter assembly 218. For example, theinner member 220 may comprise a guidewire lumen 221, allowing the device200 to be tracked over a guidewire (e.g., the guidewire 226 comprising apigtail distal end) without contacting the filter assembly 218. Foranother example, a lumen 221 of the inner member 220 may be fluidlycoupled to the flush port 212, which can allow flushing of fluid throughthe inner member 220, for example to remove air. For yet anotherexample, a lumen 221 of the inner member 220 may be connected to anarterial pressure monitoring device, allowing measurement of pressureproximate to the location of the filter assembly 218.

The distal portion 204 may include fluoroscopic markers 224 a, 224 b,224 c, 224 d to aid a user in positioning the device 200, deploying thefilter assembly 218, utilizing the inner member 220, etc. Thefluoroscopic marker 224 a is proximate to a distal end of the outersheath 210. The fluoroscopic marker 224 b is proximate to a proximal endof the filter assembly 218. The fluoroscopic marker 224 c is proximateto a proximal end of a ring of the filter assembly 218. The fluoroscopicmarker 224 d is proximate to a distal end of the inner member 220. Thefluoroscopic markers may comprise a radiopaque material (e.g., iridium,platinum, tantalum, gold, palladium, tungsten, tin, silver, titanium,nickel, zirconium, rhenium, bismuth, molybdenum, combinations thereof,and the like). More or fewer fluoroscopic markers are also possible.

The protection device 200 is illustrated as comprising a guidewire 226therethrough, although the guidewire 226 may be characterized as beingseparate from the protection device 200, for example independently sold,packaged, and/or directed. The guidewire 226 may extend through a lumenof the outer sheath 210. The lumen may be configured to receive aguidewire 226 having a diameter between about 0.014 inches and about0.025 inches. The guidewire 226 may extend through a lumen of the filterassembly 218. The guidewire 226 may extend through a lumen 221 of theinner member 220. For example, the protection device 200 may be trackedover the guidewire 226 to position the protection device 200 at adesired location.

FIG. 3 is a side cross-sectional view of an example proximal portion 300of a protection device (e.g., the protection device 200). The proximalportion 300 comprises a housing or shell 302 (e.g., the handle 206), adeployment tube 304, an outer sheath 306 (e.g., the outer sheath 210)around the deployment tube 304, a slider 308 (e.g., the slider 208), adeployment hub 310, a stopcock 312, a hemostatis valve/cap 314, an innermember 316 (e.g., the inner member 220), an inner member hub slider 318,and a luer fitting 320. One or more of the illustrated features mayoptionally be omitted from the proximal portion 300, for example toreduce cost, to reduce complexity, to remove features not used, etc. Theaddition of features not illustrated in FIG. 3 is also possible.

The housing 302 can hold parts of the proximal portion 300 together,protect parts from contaminants (e.g., that may interfere with use ofthe proximal portion 300), and the like. The housing 302 may be omitted,for example providing a user of the proximal portion 300 unfetteredaccess or control over every feature of the proximal portion 300. Forexample, many users are quite skilled at manipulating wires and tubeswith respect to each other such that a slider 308 or the like may reducemanipulation dexterity. For other users, a slider 306 or the like mayprovide aid in proper use, for example providing a fail-safe limitedrange of movement.

A filter wire 322 that is coupled to a filter assembly (e.g., asdescribed herein) may be coupled to the deployment tube 304 by a weld324 or other coupling means. The housing 302 allows the slider 308 tomove longitudinally, for example in a track in the housing 302, todeploy a filter assembly (e.g., out of a distal end of the outer sheath306). The deployment housing 304 can help maintain positions of elementssuch as the filter wire 322 and the outer sheath 306 during movementsuch as translation of the slider 308. The proximal portion 300 maycomprise a static seal 326 between the slider 308 and the deploymenttube 304. The housing 302 can provide ergonomic interaction between auser and the proximal portion 300.

The luer fitting 320 allows the proximal portion 300 to be flushed(e.g., with saline) prior to use (e.g., through the lumen of the innermember 316), for example to remove air. The luer fitting 320 may be usedto couple the inner member 316 to a pressure monitoring device. Theproximal portion 300 is illustrated with a guidewire 328 extendingthrough a lumen of the inner member 316, indicative that the lumen ofthe inner member 316 may be used to guide a protection device to alocation by tracking over the guidewire 328. The stopcock 312 includes aluer fitting port 313 in fluid communication with the outer sheath lumen221 and is suitable for use in monitoring arterial blood pressure. Ifthe inner member 316 is too small for an accurate measurement or if theinner member 316 is omitted, the outer sheath 304 can provide the fluidlumen used to measure blood pressure.

A lock 315 may be provided to releasably engage the inner member 316 toinhibit or prevent the inner member 316 from moving with respect to thehub 310. Other interaction mechanisms are also possible.

FIG. 4A illustrates an example distal portion 400 of a protection device(e.g., the protection device 200) in a collapsed or delivery state orshape with the filter retracted within the outer sheath 402. FIG. 4Billustrates the example distal portion 400 of FIG. 4A in an expanded ordeployed state or shape with the outer sheath 402 retracted to exposethe filter assembly 406. The distal portion 400 comprises an outersheath 402 (e.g., the outer sheath 210), a radiopaque marker or band 404(e.g., the radiopaque marker 224 a), a filter assembly 406 (e.g., thefilter assembly 218), an inner member 416 (e.g., the inner member 220),a radiopaque marker or band 419 (e.g., the radiopaque marker 224 d), anda guide tube 414. One or more of the illustrated features may optionallybe omitted from the distal portion 400, for example to reduce cost, toreduce complexity, to remove features not used, etc. The addition offeatures not illustrated in FIGS. 4A-4D is also possible.

The radiopaque marker 404 may be proximate to the distal end of theouter sheath 402 to help guide the distal end of the outer sheath 402into a delivery location (e.g., the left subclavian artery upstream ofthe left vertebral artery, or the left vertebral artery). The radiopaquemarker 404 may be positioned to aid a user in determining a deployedposition of the filter assembly 406, for example accounting forforeshortening upon radial expansion. Once the radiopaque marker 404 isaligned with a target location or some distance proximal or distal tothe target location, the filter assembly 406 can be deployed, or thedistal portion 400 may be advanced or retracted a certain distancebefore the filter assembly 406 is deployed. The radiopaque marker 404may be omitted (e.g., by using a radiopaque portion of the filterassembly 406). The radiopaque marker 404 may be used to determine adegree of deployment of the filter assembly 406. For example, if theproximal end of the filter assembly 406 comprises a radiopaque marker orband such as the radiopaque marker or band 224 b in FIG. 2, fulldeployment of the filter assembly 406 may be indicated by the radiopaquemarker 224 b being aligned with the radiopaque marker 404 and/or distalto the radiopaque marker 404. The radiopaque marker 404 may be used todetermine a degree of retraction of the inner member 416. For example,retraction of the distal end of the inner member 416 into the outersheath 401 may be indicated by the radiopaque marker 419 being alignedwith the radiopaque marker 404 and/or proximal to the radiopaque marker404.

In the delivery state illustrated in FIG. 4A, the filter assembly 406 iswithin outer sheath 402. In the delivery state, the distal portion 400is radially compact, which can facilitate navigation through vasculature(e.g., through vasculature of the arm). As described herein, the outersheath 402 and the filter assembly 406 are longitudinally movablerelative to each other. When a position of the filter assembly 406 isdistal to a position of the outer sheath 402 (e.g., due to proximalretraction of the outer sheath 402 and/or distal advancement of thefilter assembly 406 via the filter wire 417 via the guide tube 414), thefilter assembly 406 exits the distal end of the outer sheath 402 andself-expands to the deployed state illustrated in FIG. 4B. The innermember 416 may be movable independent of the outer sheath 402 and thefilter assembly 406. In the deployed state, the filter assembly 406 caninhibit embolic material from entering cerebral vasculature (e.g., byfiltering blood flowing to the left vertebral artery).

The filter assembly 406 comprises a support element or frame 408 and afilter element 410. The frame 408 generally provides expansion supportto the filter element 410 in the expanded state. In the expanded state,the filter element 410 is configured to filter fluid (e.g., blood)flowing through the filter element 410 and to inhibit or preventparticles (e.g., embolic material) from flowing through the filterelement 410 by capturing the particles in the filter element 410.

The guide tube 414 and/or the outer sheath 402 may comprise a lumen inwhich portions of the frame 408 (e.g., longitudinal portions) arecoupled (e.g., adhesively joined, banded, crimped, welded, soldered,etc.) to a filter wire 417. The coupled portions of the frame 408 andfilter wire 417 may be in a lumen 423 of a crimp tube 422 that is in theguide tube 414. FIG. 4C is a cross-sectional view of the distal portion400 of FIGS. 4A and 4B along the line 4C-4C of FIG. 4B. FIG. 4C showsthe guidewire 418 in the inner member 416, which is in the outer sheath402. A crimp tube 422 is also in the outer sheath 402. The filter wire417 and wires 409 a, 409 b of the frame 408 of the filter assembly 406are coupled in the crimp tube 422. FIG. 4D is an enlarged view of partof the distal portion 400 of FIGS. 4A and 4B. A proximal portion of thecrimp tube 422 is coupled to the filter wire 417 by a crimp 424 and adistal portion of the crimp tube 422 is coupled to the wires 409 a, 409b of the frame 408 of the filter assembly 406 by a plurality oflongitudinally offset crimps 426. Other coupling mechanisms as describedherein are also possible. The guide tube 414 may provide a platform forplacement of radiopaque bands. The inner member 416 may extend throughthe lumen of the guide tube 414.

The inner member 416 may extend the length of the filter assembly 406 inthe compressed state, for example to inhibit or prevent the guidewire418 from interacting with the filter assembly 406, thereby inhibiting orpreventing the filter assembly 406 from binding the guidewire 418 duringnavigation. Foreshortening of the filter assembly 406 during deploymentmay result in the inner member 420 extending distally to the filterassembly 408 after deployment of the filter assembly 406, possibly intothe aortic arch. The inner member 420 may be proximally retracted (e.g.,out of the aortic arch and/or for other reasons such as positioning foruse of a therapeutic, radiopaque, or other fluid, for use with apressure monitor, etc.) after deployment of the filter assembly 406, forexample as described with respect to FIG. 6B. The inner member 420 maybe distally advanced before retraction of the filter assembly 406, forexample to inhibit or prevent the guidewire 418 from interacting withthe filter assembly 406, thereby inhibiting or preventing the filterassembly 406 from binding the guidewire 418 during navigation.

The frame 408 is configured to engage or appose the inner walls of alumen (e.g., blood vessel) in which the distal portion 400 is expanded.The frame 408 may comprise or be constructed of, for example, nickeltitanium (e.g., nitinol), nickel titanium niobium, chromium cobalt(e.g., MP35N, 35NLT), copper aluminum nickel, iron manganese silicon,silver cadmium, gold cadmium, copper tin, copper zinc, copper zincsilicon, copper zinc aluminum, copper zinc tin, iron platinum, manganesecopper, platinum alloys, cobalt nickel aluminum, cobalt nickel gallium,nickel iron gallium, titanium palladium, nickel manganese gallium,stainless steel, combinations thereof, and the like. The frame 408 maycomprise a wire (e.g., having a round (e.g., circular, elliptical) orpolygonal (e.g., square, rectangular) cross-section). For example, insome embodiments, the frame 408 comprises a straight piece of nitinolwire shape set into a circular or oblong hoop or hoop with one or twostraight legs running longitudinally along or at an angle to alongitudinal axis of the distal portion 400. At least one of thestraight legs may be coupled to a filter wire 417, for example as shownin FIG. 4C. The straight legs may be on a long side of the filterassembly 406 (e.g., the bottom side as illustrated in FIG. 4B) and/or ona short side of the filter assembly 406 (e.g., the top side asillustrated in FIG. 4B). The frame 408 forms a shape of an opening 420of the filter assembly 406. The opening 420 may be circular, elliptical,or any shape that can appropriately appose sidewalls of a vessel such asthe left subclavian artery or the left vertebral artery. As shown inFIG. 4B, the filter assembly 406, for example for implementationsintended for use in the left subclavian artery, has a generallydistally-facing opening 420.

The frame 408 may include a radiopaque marker such as a small coilwrapped around or coupled to the hoop to aid in visualization underfluoroscopy. In some embodiments, the frame may not comprise a shapeother than a hoop, for example a spiral. In some embodiments, the filterassembly 406 may not include or be substantially free of a frame.

In some embodiments, the frame 408 and the filter element 410 form anoblique truncated cone having a non-uniform or unequal length around andalong the length of the filter assembly 406. In such a configuration,along the lines of a windsock, the filter assembly 406 has a largeropening 420 (upstream) diameter and a reduced ending (downstream)diameter (e.g., proximate to the filter wire).

The filter element 410 comprises pores configured to allow blood to flowthrough the filter element 410, but that are small enough to inhibitprevent particles such as embolic material from passing through thefilter element 410. The filter element 410 may comprise a filtermembrane such as a polymer (e.g., polyurethane, polytetrafluoroethylene(PTFE)) film mounted to the frame 406. The filter element may have athickness between about 0.0001 inches and about 0.03 inches (e.g., nomore than about 0.0001 inches, about 0.001 inches, about 0.005 inches,about 0.01 inches, about 0.015 inches, about 0.02 inches, about 0.025inches, about 0.03 inches, ranges between such values, etc.).

The film may comprise a plurality of pores or holes or aperturesextending through the film. The film may be formed by weaving orbraiding filaments or membranes and the pores may be spaces between thefilaments or membranes. The filaments or membranes may comprise the samematerial or may include other materials (e.g., polymers, non-polymermaterials such as metal, alloys such as nitinol, stainless steel, etc.).The pores of the filter element 410 are configured to allow fluid (e.g.,blood) to pass through the filter element 410 and to resist the passageof embolic material that is carried by the fluid. The pores can becircular, elliptical, square, triangular, or other geometric shapes.Certain shapes such as an equilateral triangular, squares, and slots mayprovide geometric advantage, for example restricting a part larger thanan inscribed circle but providing an area for fluid flow nearly twice aslarge, making the shape more efficient in filtration verses fluidvolume. The pores may be laser drilled into or through the filterelement 410, although other methods are also possible (e.g., piercingwith microneedles, loose braiding or weaving). The pores may have alateral dimension (e.g., diameter) between about 10 micron (μm) andabout 1 mm (e.g., no more than about 10 μm, about 50 μm, about 100 μm,about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 400 μm,about 500 μm, about 750 μm, about 1 mm, ranges between such values,etc.). Other pore sizes are also possible, for example depending on thedesired minimum size of material to be captured.

The material of the filter element 410 may comprise a smooth and/ortextured surface that is folded or contracted into the delivery state bytension or compression into a lumen. A reinforcement fabric may be addedto or embedded in the filter element 410 to accommodate stresses placedon the filter element 410 during compression. A reinforcement fabric mayreduce the stretching that may occur during deployment and/or retractionof the filter assembly 406. The embedded fabric may promote a folding ofthe filter to facilitate capture of embolic debris and enable recaptureof an elastomeric membrane. The reinforcement material could comprise,for example, a polymer and/or metal weave to add localized strength. Thereinforcement material could be imbedded into the filter element 410 toreduce thickness. For example, imbedded reinforcement material couldcomprise a polyester weave mounted to a portion of the filter element410 near the longitudinal elements of the frame 408 where tensile forcesact upon the frame 408 and filter element 410 during deployment andretraction of the filter assembly 406 from the outer sheath 402.

A fluid (e.g., blood) flows through the opening 420 and passes throughthe pores in the filter element 410, while the filter element 410 trapsparticles (e.g., embolic material) to inhibit or prevent passage to alocation downstream of the filter assembly 406 such as the cerebralvasculature.

The distal portion 400 is illustrated with a guidewire 418 extendingthrough a lumen of the inner member 416, indicative that the lumen ofthe inner member 416 may be used to guide a protection device to alocation by tracking over the guidewire 418.

FIGS. 5A-5I illustrate optional variations on the protection devicesdescribed above. One or more of the variations may be applied, or allmay be omitted. One or more of the variations may be applied to otherprotection devices described herein.

FIG. 5A illustrates an example guidewire loading tool 500. A kit maycomprise a protection device as described herein and the guidewireloading tool 500. The guidewire loading tool has a funnel shape 502configured to facilitate placement of a proximal end of a guidewire intothe protection device (e.g., into the lumen of the inner member of aprotection device). The narrow portion of the funnel shape 502 may besized to fit in a distal end of an inner member. The narrow portion ofthe funnel shape 502 may be sized to fit around a distal end of an innermember. In certain such implementations, the funnel shape 502 maycomprise a step configured to interact with the distal end of the innermember to reduce or eliminate a step due to a blunt distal end of aninner member. The guidewire loading tool 500 may include indicia 504 tocaution that the guidewire loading tool 500 is temporary and should beremoved prior to tracking the protection device over the guidewire. Aprotection device may be packaged with the guidewire loading tool 500 inplace (e.g., engaged with an inner member), for example to reduce oreliminate the user from engaging the guidewire loading tool 500 with aprotection device. The guidewire loading tool or packaging insert 500can protect the filter frame from being damaged in shipping and handlingand protects the filter film during loading of the inner member and/orguidewire during initial assembly.

FIG. 5B illustrates an example coupling system 510. The coupling system510 may couple a filter assembly 512 to a filter wire 514, for exampleby way of a guide tube 516. Referring again to the guide tube 414illustrated in FIG. 4B, the proximal end of the guide tube 414 may bedistal to the distal end of the outer sheath 402 when the filterassembly 406 is deployed. If the filter assembly 406 is retracted backinto the outer sheath 402, the proximal end of the guide tube 414 maycatch or snag on the distal end of the outer sheath 402, inhibiting orpreventing retraction and/or dislodging embolic material captured by thefilter assembly 406. The guide tube 516 of the coupling system 510comprises a chamfered proximal end 518 configured to inhibit or preventthe proximal end 518 from catching or snagging on the distal end of anouter sheath. The chamfered proximal end may aid in routing the filterwire 514 through the protection device and/or coupling to the filterassembly 512. The coupling system 510 optionally comprises radiopaquemarker bands 520, 522 that may aid a user in placement of the filterassembly 512 at a location. The use of a pair of bands for theradiopaque marker 520 may differentiate distal from proximal. The filterwire 514 may be coupled to wires of the frame of the filter assembly 512by a crimp tube (e.g., a crimp tube 422 as described with respect toFIGS. 4B-4D) in the guide tube 516 or proximal to the guide tube 516.The angled proximal end 514 can facilitate loading of proximal bond intoan outer sheath during initial assembly since, if the filter assembly512 is extended beyond the outer sheath, a square or perpendicular cutmay get caught on the distal end of the outer sheath.

FIG. 5C illustrates another example coupling system 530. The innermember 532 extends distal to the filter assembly 536. The inner member532 comprises an atraumatic tapered distal tip 534. The atraumatictapered distal tip 534 can provide easier advancement of the innermember 532 through vasculature (e.g., if the inner member 532 is distalto the distal end of an outer sheath such as illustrated in FIG. 4A).The atraumatic tapered distal tip 534 can provide easier advancement ofthe inner member 532 through the filter assembly 536 (e.g., a bondregion of a filter wire and frame wires), for example after the innermember 532 has been retracted for pressure sensing, to be out of theaortic arch, etc. The atraumatic tapered distal tip 534 can provideeasier interaction with a tapered proximal end of a guide tube (e.g.,the proximal end 518 of the guide tube 516 shown in FIG. 5B). Theatraumatic tapered distal tip 534 can provide easier tracking of theprotection device over the guidewire 538 and through the vasculature.

FIG. 5D illustrates an example inner member manipulation tool 540.Tubing of the inner member may be floated through an area where a filterassembly is coupled to a filter wire and routed to a handle. The innermember may be coupled to a luer fitting 542, which can be manipulated todistally advance and/or longitudinally retract the inner member. AY-connector includes a male luer fitting and a hemostasis valve on a topof the Y and a female luer connection on a bottom of the Y. The femaleluer connection can be connected to a guide catheter or outer sheath.The male luer fitting can be used for connection to a blood pressuresensing device. A filter deployment wire and inner member can be routedthrough the hemostasis valve of the male luer fitting to create a seal.The luer fitting 542 may provide an interface for a syringe (e.g., toflush the protection device and/or the vessel, to provide contrastagent, etc.), a pressure monitor, etc.

FIG. 5E illustrates an example coupling system 550. A filter wire 552 iscoupled to wires 554 a, 554 b of a filter assembly frame by crimpingand/or laser welding within a barrel 556 that is proximal to a guidetube 558. One wire, two wires (e.g., as shown in FIG. 5E), or more arepossible depending on the structure of the frame of the filter assembly.The coupling may be sized to keep the filter assembly concentric in anouter sheath. The coupling may be sized (e.g., undersized) to allow forblood pressure monitoring with a guidewire in place (e.g., through theguide tube 558). The barrel 556 may comprise a chamfered proximal endconfigured to inhibit or prevent the proximal end from catching orsnagging on the distal end of an outer sheath.

FIG. 5F illustrates another example coupling system 560. The filter wireis replaced with a deployment tube 562, for example comprising a wovenor braided shaft, a laser cut or heat treated hypotube, combinationsthereof, and the like. A barrel 566 is coupled to the deployment tube562 by crimping, adhesive joining, and/or laser welding the barrel 566around the deployment tube 562. The barrel 566 may comprise a thin wall,which can provide flexibility of the barrel 566. Wires 564 a, 564 b of afilter assembly frame are coupled to the barrel 566, for example bycrimping and/or welding at site 568, which couples the filter assemblyframe to the deployment tube 562 via the barrel 566. The coupling system560 may comprise a radiopaque marker 569, for example comprising aplatinum iridium ring. The radiopaque marker or band 569 may be used tomechanically join the filter frame wires 564 a, 564 b to the guide tube5558. The radiopaque marker 569 may be coupled (e.g., crimped and/orwelded) to a distal end of the barrel 566. The wires 564 a, 564 b may beradially between the barrel 566 and the radiopaque marker 569, forexample to provide further coupling of the wires 564 a, 564 b to thebarrel 566. A guidewire may be inserted through a lumen of thedeployment tube 562. An inner member may be in a lumen of the deploymenttube 562 or outside a lumen of the deployment tube 562. Blood pressuremay be taken outside of the deployment tube 562.

FIG. 5G illustrates yet another example coupling system 570. Asdescribed with respect to the coupling system 560 of FIG. 5F and asapplicable to other coupling systems described herein, the filter wireis replaced with a deployment tube 572. The deployment tube 572 maycomprise polymer (e.g., polyimide) filaments. Wires 574 a, 574 b of afilter assembly frame are each four-way crimped to the deployment tube572. The coupling system 570 may comprise a radiopaque marker 576, forexample comprising a platinum iridium ring. Absent a guide tube, barrel,etc. that might include radiopaque markers and/or act as a stopmechanism, the radiopaque marker 576 can indicate the position of thefilter assembly. The radiopaque marker 576 may be coupled (e.g.,crimped, adhesively joined, and/or welded) to a distal end of thedeployment tube 572. The wires 574 a, 574 b may be radially between thedeployment tube 572 and the radiopaque marker 576, for example toprovide further coupling of the wires 574 a, 574 b to the deploymenttube 572. The coupling system 570 may provide a lower profile. Thecoupling system 570 may be devoid of a stiff transition between thefilter assembly frame and the deployment tube 572. An inner member maybe in a lumen of the deployment tube 572 or outside a lumen of thedeployment tube 572.

Blood pressure may be taken inside of the deployment tube 572. Forexample, if an outer sheath around the deployment tube 572 is 5 Fr(approximately 1.67 mm), then measurement of blood pressure inside thedeployment tube 572 may allow for true 5 Fr. Blood pressure may be takenoutside of the deployment tube 572, although an outer sheath around thedeployment tube 572 is preferably 6 Fr (approximately 2 mm) to obtainappropriate pressure measurements. Other diameters may also beappropriate (e.g., 5 Fr (approximately 1.67 mm) in an outer sheath orcatheter or for a needle-based system.

In some embodiments in which a protection device comprises the couplingmechanism 570, a smaller guidewire may be used, for example to fitwithin a lumen of the deployment tube 572, which may be reduced wherethe deployment tube 572 is coupled to the wires 574 a, 574 b. Aguidewire may be guided through the deployment tube 572 using a porouscentering part, which can comprise a braid-reinforced shaft. Thecoupling may rely on an interference fit between the wires 574 a, 574 band the braided shaft 572 when the band 576 is positioned over the wires574 a, 574 b and the braided shaft 572. The band 576 may be mechanicallyswaged to hold the wires 574 a, 574 b in place. The filter assembly maybe fixed to an inner member around which the deployment tube 572 ispositioned, and the guidewire may be routed through a lumen of the innermember.

FIG. 5H illustrates still another example coupling system 580. Thecoupling system 580 comprises a deployment tube 582 and a strain reliefheat shrink 586 around the distal end of the deployment tube 582. Wires584 a, 584 b of a filter assembly frame may be coupled to the deploymenttube 582, the strain relief heat shrink 586, a guide tube (e.g., asshown in FIG. 5H), other couplings described herein, and the like.

FIG. 5I illustrates yet still another example coupling system 590. Thecoupling system 590 comprises deployment tube 592 comprising a recess594 in which a portion of a barrel such as a laser-cut tubing may becoupled (e.g., crimped). The recess 594 may be formed, for example bylaser ablation of the deployment tube 592. The recess 594 and barrelportion may create mechanical interference, for example for coupling thedeployment tube 592 to wires of a filter assembly frame. The couplingsystem 590 may comprise a radiopaque band 596 coupled to a distal end ofthe deployment tube 592.

FIGS. 6A and 6B illustrate method of using an example distal portion ofa protection device 600 in a deployed state in vasculature. A user wouldlike to protect cerebral vasculature (e.g., the left vertebral artery624) from embolic debris during an endovascular procedure such as TAVI.The user has decided to place the filter assembly 602 in the leftsubclavian artery 616 upstream of the left vertebral artery 624. Theuser may choose a protection device 600 comprising a distal-facingfilter assembly 602 having a diameter between about 7 mm and about 12mm. The protection device 600 may be packaged in a sterile coiledpackaging. The protection device 600 may comprise an outer sheath 604having a diameter of about 5 Fr (approximately 1.67 mm). The outersheath 604 may include a curvature, for example complementing the sizeand orientation of the filter assembly 602. The outer sheath 604 may besteerable (e.g., a pullwire-controlled sheath).

Lumens of the protection device 600, for example a lumen of the outersheath 604 and a lumen of the inner member 606, may be flushed (e.g.,using saline) once or several times before, during, and/or after theprocedure. The filter assembly 602 of the protection device 600 may beflushed and/or submerged (e.g., in a bowl of saline). Flushing and/orsubmerging of the filter assembly 602 may be with the filter assembly602 in the outer sheath 604 (e.g., in the compressed state) and/or withthe filter assembly 602 out of the outer sheath 604 (e.g., in thedeployed state). If the filter assembly 602 is flushed and/or submergedin the deployed state, the filter assembly 602 may be compressed intothe outer sheath 604 before use.

An artery in the left arm is accessed, for example using a 5 Frintroducer. A guidewire (e.g., having a diameter between about 0.014inches and about 0.25 inches) is steered, traversing retrograde to bloodflow, into or towards the left subclavian artery 616. A proximal end ofthe guidewire may be inserted into a distal end of the protection device600, for example into a distal end of an inner member 606. Theprotection device 600 may be tracked over the guidewire until the distalend of the protection device 600 extends beyond a distal end of theintroducer. In some implementations, the guidewire and the protectiondevice 600 may be tracked together, with the guidewire leading thedevice 600 (e.g., advance the guidewire a distance, then advance thedevice 600 over the guidewire approximately the same distance). Theguidewire and the inner member 606 may both be floppy or lack rigidity,they may be introduced inside the outer sheath 604 and then advancedahead of the device 600 in the vasculature. The guidewire may beadvanced at least about 6 centimeters (cm) distal to the distal end ofthe protection device 600.

The protection device 600 may be tracked or distally advanced over theguidewire until the distal end of the protection device 600 is at adesired location such as proximate to the left subclavian artery ostium617, just above the aortic arch 610. Tracking of the protection device600 may be under fluoroscopy, for example using radiopaque markers(e.g., at a distal end of the outer sheath 604 and/or the inner member606) and/or radiopaque fluid or contrast media. Radiopaque fluid may beprovided through the inner member 606 or outer sheath 604. Theprotection device 600 is preferably positioned so that the filterassembly 602 is upstream of the left vertebral artery 624 or morepreferably proximate to the ostium 617 so that the filter assembly 602can inhibit or prevent embolic material from entering the cerebralvasculature through the left vertebral artery 624. Using terminology ofthe procedure rather than blood flow, the protection device 600 ispreferably positioned so that the filter assembly 602 is distal to thepoint in the left subclavian artery 616 where the left vertebral artery624 branches off. Positioning may be based on available anatomy.

Once the protection device 600 is in position, the filter assembly 602may be deployed from the outer sheath 604. For example, the outer sheath604 may be proximally retracted and/or the filter assembly 602 may bedistally advanced. Radiopaque markers, for example on the filterassembly 602 can help determine when the filter assembly 602 achieves adeployed state. Differential longitudinal movement of the filterassembly 602 and the outer sheath 604 can cease upon full or appropriatedeployment of the filter assembly 602. Apposition of the filter assembly602 with sidewalls of the left subclavian artery 616 can be verified,for example using radiopaque fluid or contrast media. Radiopaque fluidmay be provided through the inner member 606. If the radiopaque fluid isable to flow between the frame of the filter assembly 602 and thesidewalls of the left subclavian artery 616, then the filter assembly602 may be improperly positioned (e.g., indicative of inadequatedeployment, inadequate sizing, calcium, etc.). The filter assembly 602may be retracted back into the outer sheath 604 and redeployed, or adifferent protection device may be used.

As shown in FIG. 6A, during positioning of the protection device 600,the inner member 606 may distally extend from the filter assembly 602into the aortic arch 610. As shown in FIG. 6B, the inner member 606 maybe proximally retracted as indicated by the arrow 626 so that the aorticarch 610 is free or substantially free of any equipment involved inprotecting the left subclavian artery 616 and/or the left vertebralartery 624. Radiopaque markers (e.g., on the inner member 606, the outersheath 604, the filter assembly 602) and/or radiopaque fluid or contrastmedia can confirm the position of the inner member 606 before, during,and/or after proximal retraction of the inner member 606. Radiopaquefluid may be provided through the inner member 606. In embodiments inwhich the protection device lacks an inner member, retraction of aninner member is moot.

The inner member 606 may be retracted to a position suitable formonitoring or sensing blood pressure. For example, a blood pressuremonitoring device can be connected in fluid communication to the innermember 606 (e.g., using a luer fitting). In embodiments in which theprotection device lacks an inner member, blood pressure may be monitoredor sensed by connecting a blood pressure monitoring device to the outersheath 604.

With the protection device 600 in place, the filter assembly 602deployed, and the inner member 606 retracted, the user or a differentuser can perform an endovascular procedure (e.g., TAVI, TAVR, TAMI,TAMR, SAVR, other surgical valve repair, implantation, or replacement,cardiac ablation, cardiac bypass surgery, etc.). If the endovascularprocedure accesses the heart via the aortic arch 610, such access is notimpeded by the protection device 600. During the endovascular procedure,any embolic material that is dislodged or generated may be carried byblood into the left subclavian artery 616. The blood may continue toflow through the filter assembly 602 (e.g., through pores in a film ofthe filter assembly 602), but the embolic material is trapped orcaptured such that the embolic material is inhibited or prevented fromcontinuing to flow through the left subclavian artery 616, into the leftvertebral artery 624, and thus into the cerebral vasculature.

Once the endovascular procedure is complete, or at any appropriate pointduring the endovascular procedure, the filter assembly 602 may beretracted back into the outer sheath 604 (e.g., by distally advancingthe outer sheath 604 and/or by proximally retracting the filterassembly). The action to resheathe the filter assembly 602 may byopposite to the action to unsheathe the filter assembly 602 (e.g.,retraction of a slider and advancement of the slider, respectively) ormay be a completely different action. The inner member 606 may bedistally advanced before, during, or after resheathing the filterassembly 602. Radiopaque markers, for example on the filter assembly 602can help determine when the filter assembly 602 achieves a compressedstate. Differential longitudinal movement of the filter assembly 602 andthe outer sheath 604 can cease upon full or appropriate capture of thefilter assembly 602. Radiopaque fluid may be provided through the innermember 606. Embolic material trapped in the filter assembly 602 may alsobe captured by the resheathing process. Once the protection device 600is in a compressed state, the protection device 600 may be proximallyretracted out of the left subclavian artery 616.

The protection devices described herein may be used alone or incombination with other protection devices. For example, a secondprotection device as described herein may be advanced via the rightsubclavian artery and positioned in the innominate artery, providingprotection to the right carotid artery and the right vertebral artery.For another example, an aortic arch filter or deflector such as theEmbrella Embolic Deflector System, the TriGuard embolic protectionsystem, or the like may be placed across the great branch artery ostiaand/or apposing sidewalls of the aortic arch upstream of at least one ofthe great branch artery ostia.

For another example, the filter systems and methods described in U.S.Pat. No. 8,876,796 can be used in combination with the protectiondevices described herein to further protect the cerebral vasculatureduring an endovascular procedure. FIG. 7 illustrates an example distalportion of a protection device 700 in a deployed state in the leftsubclavian artery in combination with a second protection device. Toprotect the right common carotid artery and the right vertebral artery(both branching downstream from the innominate artery 712) and the leftcommon carotid artery 714 during endovascular procedures, a filtersystem as described in U.S. Pat. No. 8,876,796 enters the aorta 710 fromthe innominate artery 712. A distal rear-facing filter assembly 754 maybe deployed in the left common carotid artery 714 and a proximalfront-facing filter 752 may be deployed in the innominate artery 712.FIG. 7 also illustrates a protection device 700 including a filterassembly 702 deployed from an outer sheath 704 in the left subclavianartery upstream of the left vertebral artery 724, for example similar tothe procedure described with respect to FIG. 6B. The filter assemblies702, 752, 754 can inhibit or prevent embolic material from enteringcerebral vasculature through any of the left vertebral artery 724, theright vertebral artery, the right common carotid artery, and the leftcommon carotid artery 714.

FIG. 8 illustrates an example distal portion 800 of a protection devicein a deployed state. In contrast to the distal portions 204, 400, etc.described herein that comprise a distal-facing filter assembly, thedistal portion 800 comprises a proximal or rear-facing filter assembly806. Other aspects of the distal portion 800 may be similar to thedistal portions of other protection devices described herein.

The distal portion 800 comprises an outer sheath 802 (e.g., the outersheath 210), a radiopaque marker band 804, a filter assembly 806 (e.g.,the filter assembly 218), an inner member 816 (e.g., the inner member220), and a slotted coupler 812. One or more of the illustrated featuresmay optionally be omitted from the distal portion 800, for example toreduce cost, to reduce complexity, to remove features not used, etc. Theaddition of features not illustrated in FIG. 8 is also possible.

The outer sheath 802 may include a curvature and/or be steerable, forexample to turn a distal end of the distal portion 800 from the leftsubclavian artery into the left vertebral artery. For example, the outersheath 802 may include one or more features described with respect tothe left common carotid artery filter assemblies in U.S. Pat. No.8,876,796. The distal end of the outer sheath 802 may have a softatraumatic tip. The slotted coupler 812, which couples wires of theframe 808 of the filter assembly 806 to a filter wire, for example asdescribed with respect to any of the coupling mechanisms describedherein, may comprise slots to aid the slotted coupler 812 in bending(e.g., into the left vertebral artery). The wires of the frame 808 mayform an inclined strut connecting the open end of the filter assembly806 to the slotted coupler 812, which can help to radially compress thefilter assembly 806 upon interaction with outer sheath 802.

The radiopaque marker 804 may be proximate to the distal end of theouter sheath 802 to help guide the distal end of the outer sheath 802into a delivery location (e.g., the left vertebral artery). Theradiopaque marker 804 may be positioned to aid a user in determining adeployed position of the filter assembly 806, for example accounting forforeshortening upon radial expansion. Once the radiopaque marker 804 isaligned with a target location or some distance proximal or distal tothe target location, the filter assembly 806 can be deployed, or thedistal portion 800 may be advanced or retracted a certain distancebefore the filter assembly 806 is deployed. As described with respect tothe radiopaque marker 404, the radiopaque marker 804 may be used as alandmark with reference to the radiopaque marker 224 b, for example todetermine a degree of deployment of the filter assembly 602. Theradiopaque marker 804 may be omitted (e.g., by using a radiopaqueportion of the filter assembly 806).

In a delivery state, which may appear the same as the delivery state ofthe distal portion 400 illustrated in FIG. 4A, the distal portion 800 isradially compact, which can facilitate navigation through vasculature(e.g., through vasculature of the arm). As described herein, the outersheath 802 and the filter assembly 806 are longitudinally movablerelative to each other. When a position of the filter assembly 806 isdistal to a position of the outer sheath 802 (e.g., due to proximalretraction of the outer sheath 802 and/or distal advancement of thefilter assembly 806 via the filter wire), the outer sheath 802 exits thedistal end of the outer sheath 802 and self-expands to the deployedstate illustrated in FIG. 8. The inner member 816 may be movableindependent of the outer sheath 802 and the filter assembly 806. In thedeployed state, the filter assembly 806 can inhibit embolic materialfrom entering cerebral vasculature (e.g., by filtering blood flowing inthe left vertebral artery).

The filter assembly 806 comprises a support element or frame 808 and afilter element 810. The frame 808 generally provides expansion supportto the filter element 810 in the expanded state. In the expanded state,the filter element 810 is configured to filter fluid (e.g., blood)flowing through the filter element 810 and to inhibit or preventparticles (e.g., embolic material) from flowing through the filterelement 810 by capturing the particles in the filter element 810.

The frame 808 is configured to engage or appose the inner walls of alumen in which the distal portion 800 is expanded. The frame 808 maycomprise or be constructed of, for example, nickel titanium (e.g.,nitinol), nickel titanium niobium, chromium cobalt (e.g., MP35N, 35NLT),copper aluminum nickel, iron manganese silicon, silver cadmium, goldcadmium, copper tin, copper zinc, copper zinc silicon, copper zincaluminum, copper zinc tin, iron platinum, manganese copper, platinumalloys, cobalt nickel aluminum, cobalt nickel gallium, nickel irongallium, titanium palladium, nickel manganese gallium, stainless steel,combinations thereof, and the like. The frame 808 may comprise a wire(e.g., having a round (e.g., circular, elliptical) or polygonal (e.g.,square, rectangular) cross-section). For example, in some embodiments,the frame 808 comprises a straight piece of nitinol wire shape set intoa circular or oblong hoop or hoop with one or two straight legs runninglongitudinally along or at an angle to the longitudinal axis of thedistal portion 800. At least one of the straight legs may be coupled toa filter wire. The straight legs may be on a long side of the filterassembly 806 (e.g., the top side as illustrated in FIG. 8) and/or on ashort side of the filter assembly 806 (e.g., the bottom side asillustrated in FIG. 8). The frame 808 forms a shape of an opening 820 ofthe filter assembly 806. The opening 820 may be circular, elliptical, orany shape that can appropriately appose sidewalls of a vessel such asthe left subclavian artery or the left vertebral artery. The opening 820faces proximally, in contrast to distal-facing devices described herein.

The frame 808 may include a radiopaque marker such as a small coil toaid in visualization under fluoroscopy. In some embodiments, the framemay not comprise a shape other than a hoop, for example a spiral. Insome embodiments, the filter assembly 806 may not include or besubstantially free of a frame.

In some embodiments, the frame 808 and the filter element 810 form anoblique truncated cone having a non-uniform or unequal length around andalong the length of the filter assembly 806. In such a configuration,along the lines of a windsock, the filter assembly 806 has a largeropening 820 (upstream) diameter (e.g., proximate to the filter wire) anda reduced ending (downstream) diameter.

The filter element 810 comprises pores configured to allow blood to flowthrough the filter element 810, but that are small enough to inhibitprevent particles such as embolic material from passing through thefilter element 810. The filter element 810 may comprise a polymer (e.g.,polyurethane, PTFE) film mounted to the frame 806. The filter elementmay have a thickness between about 0.0001 inches and about 0.03 inches(e.g., no more than about 0.0001 inches, about 0.001 inches, about 0.005inches, about 0.01 inches, about 0.015 inches, about 0.02 inches, about0.025 inches, about 0.03 inches, ranges between such values, etc.).

The polymer film may comprise a plurality of pores or holes or aperturesextending through the film. The polymer film may be formed by weaving orbraiding filaments or membranes and the pores may be spaces between thefilaments or membranes. The filaments or membranes may comprise the samematerial or may include other materials (e.g., non-polymer materialssuch as metal, alloys such as nitinol, stainless steel, etc.). The poresof the filter element 810 are configured to allow fluid (e.g., blood) topass through the filter element 810 and to resist the passage of embolicmaterial that is carried by the fluid. The pores can be circular,elliptical, square, triangular, or other geometric shapes. Certainshapes such as an equilateral triangular, squares, and slots may providegeometric advantage, for example restricting a part larger than aninscribed circle but providing an area for fluid flow nearly twice aslarge, making the shape more efficient in filtration verses fluidvolume. The pores may be laser drilled into or through the filterelement 810, although other methods are also possible (e.g., piercingwith microneedles, loose braiding or weaving). The pores may have alateral dimension (e.g., diameter) between about 1 micron (μm) and about1 mm (e.g., about 1 μm, about 5 μm, about 10 μm, about 50 μm, about 100μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 800μm, about 500 μm, about 750 μm, about 1 mm, ranges between such values,etc.). Other pore sizes are also possible.

The material of the filter element 810 may comprise a smooth and/ortextured surface that is folded or contracted into the delivery state bytension or compression into a lumen. A reinforcement fabric may be addedto or embedded in the filter element 810 to accommodate stresses placedon the filter element 810 during compression. A reinforcement fabric mayreduce the stretching that may occur during deployment and/or retractionof the filter assembly 806. The reinforcement material could comprise,for example, a polymer and/or metal weave to add localized strength. Thereinforcement material could be imbedded into the filter element 810 toreduce thickness. For example, imbedded reinforcement material couldcomprise a polyester weave mounted to a portion of the filter element810 near the longitudinal elements of the frame 808 where tensile forcesact upon the frame 808 and filter element 810 during deployment andretraction of the filter assembly 806 from the outer sheath 802.

A fluid (e.g., blood) flows through the opening 820 and passes throughthe pores in the filter element 810, while the filter element 810 trapsparticles (e.g., embolic material) to inhibit or prevent passage to alocation downstream of the filter assembly 806 such as the cerebralvasculature.

The distal portion 800 is illustrated with a guidewire 818 extendingthrough a lumen of the inner member 816, indicative that the lumen ofthe inner member 816 may be used to guide a protection device to alocation by tracking over the guidewire 818.

FIGS. 9A and 9B illustrate method of using an example distal portion ofa protection device 900 in a deployed state in vasculature. A user wouldlike to protect cerebral vasculature (e.g., the left vertebral artery924) from embolic debris during an endovascular procedure such as TAVI.The user has decided to place the filter assembly 902 in the leftvertebral artery 924. The user may choose a protection device 900comprising a proximal-facing filter assembly 902 having a diameterbetween about 2 mm and about 4.5 mm. The protection device 900 may bepackaged in a sterile coiled packaging. The protection device 900 maycomprise an outer sheath 904 having a diameter of about 5 Fr(approximately 1.67 mm). The outer sheath 904 may include a curvature,for example complementing the size and orientation of the filterassembly 902. The outer sheath 904 may be steerable (e.g., apullwire-controlled sheath).

Lumens of the protection device 900, for example a lumen of the outersheath 904 and a lumen of an inner member, may be flushed (e.g., usingsaline) once or several times before, during, and/or after theprocedure. The filter assembly 902 of the protection device 900 may beflushed and/or submerged (e.g., in a bowl of saline). Flushing and/orsubmerging of the filter assembly 902 may be with the filter assembly902 in the outer sheath 904 (e.g., in the compressed state) and/or withthe filter assembly 902 out of the outer sheath 904 (e.g., in thedeployed state). If the filter assembly 902 is flushed and/or submergedin the deployed state, the filter assembly 902 may be compressed intothe outer sheath 904 before use.

An artery in the left arm is accessed, for example using a 5 Frintroducer. A guidewire 918 (e.g., having a diameter between about 0.014inches and about 0.25 inches, preferably on the smaller side in view ofintended navigation to the relatively small left vertebral artery 924)is steered, traversing retrograde to blood flow, into or towards theleft subclavian artery 916. A proximal end of the guidewire 918 may beinserted into a distal end of the protection device 900, for exampleinto a distal end of an inner member. The protection device 900 may betracked over the guidewire 918 until the distal end of the protectiondevice 900 extends beyond a distal end of the introducer. The guidewire918 may be advanced at least about 6 cm distal to the distal end of theprotection device 900. FIG. 9A shows the guidewire 918 in position inthe left vertebral artery 924 with the protection device 900 beingtracked over the guidewire 918. The guidewire 918 may comprise a pigtailor floppy distal end, for example to make the guidewire 918 atraumaticor more atraumatic.

The protection device 900 may be tracked or distally advanced over theguidewire 918 until the distal end of the protection device 900 is at adesired location such as in the left vertebral artery 924. Tracking ofthe protection device 900 may be under fluoroscopy, for example usingradiopaque markers (e.g., at a distal end of the outer sheath 904 and/oran inner member) and/or radiopaque fluid or contrast media. Radiopaquefluid may be provided through an inner member. The protection device 900is preferably positioned so that the filter assembly 902 is downstreamof the left vertebral artery 924 ostium so that the filter assembly 902can inhibit or prevent embolic material from entering the cerebralvasculature through the left vertebral artery 924. The location in theleft vertebral artery 924 is preferably free or substantially free ofcalcium and straight or substantially straight. Positioning based onavailable anatomy that is not as preferred is also possible.

Once the protection device 900 is in position, the filter assembly 902may be deployed from the outer sheath 904. For example, the outer sheath904 may be proximally retracted and/or the filter assembly 902 may bedistally advanced. Radiopaque markers, for example on the filterassembly 902 can help determine when the filter assembly 902 achieves adeployed state. Differential longitudinal movement of the filterassembly 902 and the outer sheath 904 can cease upon full or appropriatedeployment of the filter assembly 902. Apposition of the filter assembly902 with sidewalls of the left subclavian artery 916 can be verified,for example using radiopaque fluid or contrast media. Radiopaque fluidmay be provided through an inner member. If the radiopaque fluid is ableto flow between the frame of the filter assembly 902 and the sidewallsof the left vertebral artery 924, then the filter assembly 902 may beimproperly positioned (e.g., indicative of inadequate deployment,inadequate sizing, calcium, etc.). The filter assembly 902 may beretracted back into the outer sheath 904 and redeployed, or a differentprotection device may be used.

If the protection device 900 comprises an inner member, the inner membermay extend downstream in the left vertebral artery 924. Whether theinner member is retracted or not, the aortic arch 910 is free orsubstantially free of any equipment involved in protecting the leftvertebral artery 924.

An inner member may be retracted to a position suitable for monitoringor sensing blood pressure. For example, a blood pressure monitoringdevice can be connected in fluid communication to an inner member (e.g.,using a luer fitting). The distal end of an inner member may be in theleft vertebral artery 924 to monitor pressure in the left vertebralartery 924. The distal end of an inner member may be in the leftsubclavian artery 916 to monitor pressure in the left subclavian artery916. In embodiments in which the protection device lacks an innermember, blood pressure may be monitored or sensed by connecting a bloodpressure monitoring device to the outer sheath 904. The distal end ofthe outer sheath 904 may be in the left vertebral artery 924 (e.g., asillustrated in FIG. 9B) to monitor pressure in the left vertebral artery924. The distal end of the outer sheath 904 may be in the leftsubclavian artery 916 to monitor pressure in the left subclavian artery916.

With the protection device 900 in place and the filter assembly 902deployed, the user or a different user can perform an endovascularprocedure (e.g., TAVI, TAVR, TAMI, TAMR, SAVR, other surgical valverepair, implantation, or replacement, cardiac ablation, cardiac bypasssurgery, etc.). If the endovascular procedure accesses the heart via theaortic arch 910, such access is not impeded by the protection device900. During the endovascular procedure, any embolic material that isdislodged or generated may be carried by blood into the left vertebralartery 924. The blood may continue to flow through the filter assembly902 (e.g., through pores in a film of the filter assembly 902), but theembolic material is trapped or captured such that the embolic materialis inhibited or prevented from continuing to flow through the leftvertebral artery 924 and thus into the cerebral vasculature.

Once the endovascular procedure is complete, or at any appropriate pointduring the endovascular procedure, the filter assembly 902 may beretracted back into the outer sheath 904 (e.g., by distally advancingthe outer sheath 904 and/or by proximally retracting the filterassembly). The action to resheathe the filter assembly 902 may byopposite to the action to unsheathe the filter assembly 902 (e.g.,retraction of a slider and advancement of the slider, respectively) ormay be a completely different action. Radiopaque markers, for example onthe filter assembly 902 can help determine when the filter assembly 902achieves a compressed state. Differential longitudinal movement of thefilter assembly 902 and the outer sheath 904 can cease upon full orappropriate capture of the filter assembly 902. Radiopaque fluid may beprovided through an inner member. Embolic material trapped in the filterassembly 902 may also be captured by the resheathing process. Once theprotection device 900 is in a compressed state, the protection device900 may be proximally retracted out of the left vertebral artery 924.

FIG. 10 illustrates an example distal portion of a protection device1000 in a deployed state in vasculature in combination with a secondprotection device such as the filter systems and methods described inU.S. Pat. No. 8,876,796. To protect the right common carotid artery andthe right vertebral artery (both branching downstream from theinnominate artery 1012) and the left common carotid artery 1014 duringendovascular procedures, a filter system as described in U.S. Pat. No.8,876,796 enters the aorta 1010 from the innominate artery 1012. Adistal rear-facing filter assembly 1054 may be deployed in the leftcommon carotid artery 1014 and a proximal front-facing filter 1052 maybe deployed in the innominate artery 1012. FIG. 10 also illustrates aprotection device 1000 including a filter assembly 1002 deployed from anouter sheath 1004 in the left vertebral artery 1024, for example similarto the procedure described with respect to FIG. 9B. The filterassemblies 1002, 1052, 1054 can inhibit or prevent embolic material fromentering cerebral vasculature through any of the left vertebral artery1024, the right vertebral artery, the right common carotid artery, andthe left common carotid artery 1014. Embolic material may be allowed toflow downstream of the left subclavian artery 1016.

In any of the embodiments described herein, the filter assembly may bedetached from the protection device, and the remainder of the protectiondevice removed, leaving the filter assembly behind. The filter assemblycan remain in the location permanently or can be retrieved by snaringwith a retrieval catheter, for example following a post proceduretreatment duration (e.g., at least one day, one week, three weeks, fiveweeks, or more, depending upon the clinical circumstances). Subjectsreceiving an indwelling filter assembly may be administered any of avariety of thrombolytic or anticoagulant therapies, including tissueplasminogen activator, streptokinase, coumadin, heparin, combinationsthereof, and the like.

FIG. 11 illustrates another example distal portion of a protectiondevice 1100 in a deployed state in vasculature. The protection device1100 is shown as deployed across the ostium of the left subclavianartery 1116, and may extend slightly into the aorta 1110. The protection1100 device may be slightly downstream of the ostium of the leftsubclavian artery 1116, but close to the ostium is preferred. Blood canflow through the protection device 1100, but the protection device 1100deflects embolic material away from the left subclavian artery 1116. Theembolic material may flow into the descending aorta and towards thelegs. Redundant vasculature, vasculature length, vasculature diameter,natural thrombolytic agents, and the like allow embolic material to flowto the legs causing less harm than if the same embolic material flowedto the cerebral vasculature. A deflector may advantageously be smallerthan a filter, which can reduce size of the protection device 1100. Asmaller protection device 1100 may be easier to route throughvasculature, allow multiple catheters to be used, etc. A deflector mayadvantageously reduce a user's worry about capturing the embolicmaterial.

FIG. 12A illustrates an example protection device 1200. The protectiondevice 1200 is in a deployed state in FIG. 12A. The protection device1200 comprises an outer sheath 1204 and a deflector assembly 1202. Thedeflector assembly 1202 comprises a frame 1208 and a deflector film1206. The deflector film 1206 may be planar or substantially planar,convex, concave, saddle-shaped, or any other appropriate shape. Thedeflector film 1206 may comprise a membrane such as a polymer (e.g.,polyurethane, PTFE) film, a woven mesh of strands (e.g., comprising oneor more of shape memory (e.g., nitinol), metal, polymer, etc.),combinations thereof, and the like mounted to the frame 1208. Thedeflector film 1206 may have similar properties to the filter element410 and/or other films described herein (e.g., comprising poresconfigured to allow blood to flow through the deflector film 1206 but toresist the passage of embolic material that is carried by the fluid). Incontrast to the filter elements, the deflector assembly 1202 comprisesthe deflector film 1206 on a distal surface (e.g., like a potato masher)rather than having an open distal mouth and the filter element in agenerally frustoconical shape extending proximally from the mouth. Theframe 1208 comprises two wires 1210 a, 1210 b extending proximal to thedeflector film 1206. The wires 1210 a, 1210 b may be coupled to adeployment wire, deployment tube, etc., for example as described hereinwith respect to filter assembly wires. More or fewer wires are alsopossible. The deflector assembly 1202 may be collapsible into acompressed or delivery state at least partially in the outer sheath1204. The deflector assembly 1202 may have a diameter between about 8 mmand about 14 mm (e.g., about 8 mm, about 9 mm, about 10 mm, about 11 mm,about 12 mm, about 13 mm, about 14 mm, ranges between such values, andthe like). Diameters smaller than about 8 mm and larger than about 14 mmare also possible, for example depending on anatomy of a subject,location of placement, and the like. The deflector assembly 1202 may becircular, oval, ellipsoid, egg-shaped, other arcuate shapes, polygonalshapes, combinations thereof, and the like.

FIG. 12B illustrates another example protection device 1250. Theprotection device 1250 is in a deployed state in FIG. 12B. Theprotection device 1250 comprises an outer sheath 1254 and a deflectorassembly 1252. The deflector assembly 1252 comprises a frame 1258 and adeflector film 1256. The deflector film 1256 may be planar orsubstantially planar, convex, concave, saddle-shaped, or any otherappropriate shape. The deflector film 1256 may comprise a membrane suchas a polymer (e.g., polyurethane, PTFE) film mounted to the frame 1258.The deflector film 1256 may have similar properties to the filterelement 410 and/or other films, a woven mesh of strands (e.g.,comprising one or more of shape memory (e.g., nitinol), metal, polymer,etc.), combinations thereof, and the like described herein (e.g.,comprising pores configured to allow blood to flow through the deflectorfilm 1256 but to resist the passage of embolic material that is carriedby the fluid). The deflector assembly 1252 may be collapsible into acompressed or delivery state at least partially in the outer sheath1254, for example by folding like butterfly wings along an axis 1260,the axis 1260 being a distal end of the deflector assembly 1252. Theframe 1258 comprises two wires 1264 a, 1264 b extending proximal to thedeflector film 1256 and on each side of the axis 1260. The wires 1264 a,1264 b may be coupled to a deployment wire, deployment tube, etc., forexample as described herein with respect to filter assembly wires. Moreor fewer wires are also possible. The deflector film 1256, as well asother deflector films described herein, may comprise an aperture 1262configured to allow the use of an inner member, for example as describedherein. The deflector assembly 1252 may have a lateral length betweenabout 9 mm and about 18 mm (e.g., about 9 mm, about 10 mm, about 11 mm,about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about17 mm, about 18 mm, ranges between such values, and the like). Laterallengths smaller than about 9 mm and larger than about 18 mm are alsopossible, for example depending on anatomy of a subject, location ofplacement, and the like. The deflector assembly 1252 may have a lateralwidth between about 8 mm and about 14 mm (e.g., about 8 mm, about 9 mm,about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, rangesbetween such values, and the like). Lateral lengths smaller than about 8mm and larger than about 14 mm are also possible, for example dependingon anatomy of a subject, location of placement, and the like. Thedeflector assembly 1252 can be generally rectangular (length greaterthan width), square (length and width substantially equal), trapezoidal,rhomboid, other polygonal shapes, arcuate shapes, combinations thereof,and the like.

The deflector films 1206, 1256 may be placed across the ostium of theleft subclavian artery, as shown in FIG. 11. The deflector protectiondevices may be used alone or in combination with other protectiondevices as described herein. For example, the filter systems and methodsdescribed in U.S. Pat. No. 8,876,796 can be used in combination with theprotection devices 1100, 1200, 1250 described herein to further protectthe cerebral vasculature during an endovascular procedure (e.g., asunderstood by a combination of FIG. 7 with the protection device 700replaced by a deflector device as shown in FIG. 11).

FIGS. 13A-13D illustrate another example protection device 1300. Theprotection device 1300 is in a first alternative delivery state in FIG.13A. The protection device 1300 comprises an outer sheath 1308, adeflector assembly comprising a deflector film 1302, and an inner member1310. The deflector film 1302 is coupled to a distal end of the outersheath 1308 at a connection point 1304 and is coupled to a distal end ofthe inner member 1310 at a connection point 1306. The deflector film1302 may have similar properties to the filter element 410 and/or otherfilms, a woven mesh of strands (e.g., comprising one or more of shapememory (e.g., nitinol), metal, polymer, etc.), combinations thereof, andthe like described herein (e.g., comprising pores configured to allowblood to flow through the deflector film 1302 but to resist the passageof embolic material that is carried by the fluid). Use of the state ofFIG. 13A for delivery may advantageously provide the inner element forthe length of the protection device, for example inhibiting orpreventing a guidewire from interacting with the deflector film 1302.

In FIG. 13B, the inner member 1310 is retracted proximally, as indicatedby the arrow 1312. The distal end of the inner member 1310 also retractsproximally, and due to the connection point 1306, the distal portion ofthe deflector film 1302 in the delivery position retracts proximally andthe deflector film 1302 flares radially outwardly, as indicated by thearrow 1314. FIG. 13C shows the protection device 1300 in a deployedstate. Achievement of the deployed state may be indicated by alignmentof or a certain distance between the connection points 1304, 1306, whichmay include radiopaque material (e.g., radiopaque solder or adhesive).

In the deployed state, the deflector film 1302 forms a two-layeredgenerally frustoconical shape that may have similar properties to thefilter element 410 and/or other films, a woven mesh of strands (e.g.,comprising one or more of shape memory (e.g., nitinol), metal, polymer,etc.), combinations thereof, and the like described herein (e.g.,comprising pores configured to allow blood to flow through the deflectorfilm 1302 but to resist the passage of embolic material that is carriedby the fluid). While the deflector film 1302 forms a generallyfrustoconical shape in the deployed state, the protection device 1300 isdescribed herein as comprising a deflector assembly rather than a filterassembly because the embolic material may not ultimately be captured bythe deflector film 1302. For example, the embolic material may bedeflected back into the aorta if the device 1300 is returned to thefirst option delivery or withdrawal state (e.g., as shown in FIG. 13A),in which the embolic material may be allowed to flow to the descendingaorta. For another example, the embolic material may be captured if thedevice 1300 is returned to the second option delivery or withdrawalstate (e.g., as shown in FIG. 13D), in which the embolic material may becaptured in the outer sheath 1308. The device 1300 and its componentsmay appropriately be called a filter and/or a deflector based on thecontext. In an orientation forming a generally frustoconical shape suchas shown in FIGS. 13B, 13C, and 13F, the deflector assembly 1302 mayhave a mouth diameter between about 8 mm and about 14 mm (e.g., about 8mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm,about 14 mm, ranges between such values, and the like). Mouth diameterssmaller than about 8 mm and larger than about 14 mm are also possible,for example depending on anatomy of a subject, location of placement,and the like.

FIG. 13D shows a maximally contracted state in which the inner member1310 is proximally retracted until a physical limit is reached with thedeflector film 1302 fully inside the outer sheath 1308. FIG. 13D may bea second alternative delivery state of the protection device 1300, whichmay advantageously protect the deflector film 1302 during routing duringvasculature. Rather than proximally retracting the inner member 1310 toform the generally frustoconical shape of the deflector film 1302, theinner member 1310 may be distally advanced, for example as shown in FIG.13F.

A third alternative delivery state may comprise inserting a guidewireinto a distal end of the inner member 1310 in the state of FIG. 13A(e.g., using a guidewire loading tool 500) and, once the distal end ofthe guidewire is distal to the distal end of the inner member 1310,proximally retracting the inner member 1310 until the device is in thestate of FIG. 13D with the distal end of the guidewire distal to thedistal end of the outer sheath 1308 and thus the deflector film 1302.This state may provide the advantage of protecting the deflector film1302 in the outer sheath 1308 and avoid a potential disadvantage ofinteraction between the guidewire and the deflector film 1302.

FIGS. 13E and 13F are cross-sectional views of the example protectiondevice 1300 of FIGS. 13A-13D. FIG. 13E shows the device in the state ofFIG. 13D. FIG. 13F illustrates the distal advancement of the innermember 1310, as indicated by the arrow 1314, forming the generallyfrustoconical shape of the deflector film 1302, as indicated by thearrow 1316.

Regardless of the delivery shape or advancement method, the mouth of thegenerally frustoconical shape is preferably across the ostium of theleft subclavian artery. After performing a vascular procedure, the innermember 1310 can the fully distally advanced (e.g., to the state of FIG.13A) such that embolic material in the deflector film 1302 is pushedinto the aorta to then flow into the descending aorta. The protectiondevice 1300 may be used alone or in combination with other protectiondevices as described herein. For example, the filter systems and methodsdescribed in U.S. Pat. No. 8,876,796 can be used in combination with theprotection device 1300 described herein to further protect the cerebralvasculature during an endovascular procedure (e.g., as understood by acombination of FIG. 7 with the protection device 700 replaced by thedeflector device 1300).

FIG. 14 illustrates another example distal portion of a protectiondevice 1400 in a deployed state in vasculature. The protection device1400 comprises a deflector assembly 1402 and an outer sheath 1404. Theprotection device 1400 is shown as deployed across the ostium of theleft vertebral artery 1424. The deflector assembly 1402 may extendupstream and downstream of the ostium of the left vertebral artery alongthe length of the left subclavian artery 1416. Blood can flowlongitudinally through the deflector assembly 1402. Blood can also flowthrough the protection device into the left vertebral artery 1424, butthe deflector assembly 1402 deflects embolic material away from the leftvertebral artery 1424. The embolic material may flow longitudinallythrough the protection device 1400 into the portion of the leftsubclavian artery 1416 downstream of the ostium of the left vertebralartery 1424 and into the left arm. Redundant vasculature, vasculaturelength, vasculature diameter, natural thrombolytic agents, and the likeallow embolic material to flow to the left arm causing less harm than ifthe same embolic material flowed to the cerebral vasculature. Adeflector may advantageously be smaller than a filter, which can reducesize of the protection device 1400. A smaller protection device 1400 maybe easier to route through vasculature, allow multiple catheters to beused, etc. A deflector may advantageously reduce a user's worry aboutcapturing the embolic material.

FIGS. 15A-15D illustrate another example protection device 1500. Theprotection device 1500 may be positioned in the left subclavian arteryacross the ostium of the left vertebral artery similar to the protectiondevice 1400. Referring to the deployed or expanded state of FIG. 15D,the protection device 1500 comprises an outer sheath 1504 and adeflector assembly 1502. An inner member as described herein may be usedwith the protection device 1500, for example extending through thedeflector assembly 1502. The outer sheath 1504 may comprise, forexample, a braid-reinforced polymer tube. The deflector assembly 1502comprises a frame 1506 and a deflector film 1508. The frame 1506 mayhave similar properties to the frame 408 and/or other frames describedherein (e.g., providing expansion support to the deflector film 1508 inthe expanded state). The frame 1506 may comprise, for example, alaser-cut hypotube, a woven structure, etc. The deflector film 1508 mayhave similar properties to the filter element 410 and/or other films, awoven mesh of strands (e.g., comprising one or more of shape memory(e.g., nitinol), metal, polymer, etc.), combinations thereof, and thelike described herein (e.g., comprising pores configured to allow bloodto flow through the deflector film 1508 but to resist the passage ofembolic material that is carried by the fluid). The deflector film 1508may comprise, for example, a microporous structure comprising poreshaving diameters between about 60 μm and about 200 μm, and comprising abraided structure, a drilled polymer, an expanded polymer, etc. Theframe 1506 comprises wires or struts 1510 extending proximal to thedeflector film 1508. The wires 1510 may be coupled to a deployment wire,deployment tube, etc., for example as described herein with respect tofilter assembly wires. The deflector assembly 1502 may be collapsibleinto a compressed or delivery state at least partially in the outersheath 1504.

FIG. 15A shows the protection device 1500 in a delivery state in whichthe deflector assembly is not visible because it is in the outer sheath1504. FIG. 15A also shows a guidewire 1518 over which the protectiondevice 1500 can be tracked. FIG. 15B shows the outer sheath 1504 beingproximally retracted, as indicated by the arrow 1512, allowing thedeflector assembly 1502 to self-expand radially outwardly (e.g., due tothe deflector assembly 1502 being coupled to a deployment wire that isheld stationary and/or distally advanced). FIG. 15C shows furtherretraction of the outer sheath 1504, and the deflector assembly 1502 isfully deployed in FIG. 15D. The deflector assembly 1502 may be retractedback in the outer sheath 1504 after a vascular procedure by distallyadvancing the outer sheath 1504 and/or proximally retracting thedeflector assembly 1502. The deflector assembly 1502 may have a diameterbetween about 8 mm and about 14 mm (e.g., about 8 mm, about 9 mm, about10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, rangesbetween such values, and the like). Diameters smaller than about 8 mmand larger than about 14 mm are also possible, for example depending onanatomy of a subject, location of placement, and the like. The deflectorassembly 1502 may have a cross-section that is circular (e.g., asillustrated in FIG. 15D), oval, ellipsoid, egg-shaped, other arcuateshapes, polygonal shapes, combinations thereof, and the like. Thedeflector assembly 1502 may have a length in an expanded state (e.g., asshown in FIG. 15D) between about 3 mm and about 16 mm (e.g., about 3 mm,about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about15 mm, about 16 mm, ranges between such values, and the like). Lengthslarger than about 16 mm are also possible, for example depending onanatomy of a subject, location of placement, and the like. A deflectorassembly 1502 having a length greater than a diameter of an ostium ofthe left vertebral artery (e.g., greater than about 6 mm) may providestability in the left subclavian artery, for example by providingcircumferential sidewall apposition proximal and/or distal to the ostiumof the left vertebral artery.

FIG. 16A illustrates another example distal portion of a protectiondevice 1600 in a deployed state in vasculature. FIG. 16B is across-sectional view of the example distal portion of the protectiondevice 1600 and the vasculature of FIG. 16A along the line 16B-16B ofFIG. 16A. The protection device 1600 is positioned in the leftsubclavian artery 1616 across the ostium of the left vertebral artery1624 in a deployed state. The protection device 1600 comprises an outersheath 1606 and a deflector assembly 1602. In contrast to the fullyarcuate deflector assembly 1502, the deflector assembly 1602 ispartially arcuate, as seen in FIG. 16B. An inner member as describedherein may be used with the protection device 1600, for exampleextending through the deflector assembly 1602. The deflector assembly1602 comprises a wire or strut 1604, which may be coupled to adeployment wire, deployment tube, etc., for example as described hereinwith respect to filter assembly wires. The deflector assembly 1602 maybe collapsible into a compressed or delivery state at least partially inthe outer sheath 1606, for example as described with respect to FIGS.15A-15D. The deflector assembly 1602 may have a diameter between about 8mm and about 14 mm (e.g., about 8 mm, about 9 mm, about 10 mm, about 11mm, about 12 mm, about 13 mm, about 14 mm, ranges between such values,and the like). Diameters smaller than about 8 mm and larger than about14 mm are also possible, for example depending on anatomy of a subject,location of placement, and the like. The deflector assembly 1502 mayhave a cross-section that is circular, oval, ellipsoid, egg-shaped,other arcuate shapes, polygonal shapes, combinations thereof, and thelike. The deflector assembly 1502 may have a length in an expanded state(e.g., as shown in FIG. 16) between about 3 mm and about 16 mm (e.g.,about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm,about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14mm, about 15 mm, about 16 mm, ranges between such values, and the like).Lengths larger than about 16 mm are also possible, for example dependingon anatomy of a subject, location of placement, and the like. Adeflector assembly 1602 having a length greater than a diameter of anostium of the left vertebral artery (e.g., greater than about 6 mm) mayprovide stability in the left subclavian artery, for example byproviding substantially circumferential sidewall apposition proximaland/or distal to the ostium of the left vertebral artery.

FIG. 17 illustrates another example distal portion of a protectiondevice 1700 in a deployed state in vasculature. The protection device1700 is positioned in the left subclavian artery 1716 across the ostiumof the left vertebral artery 1724 in a deployed state. The protectiondevice 1700 comprises an outer sheath 1706 and a deflector assembly1702. In contrast to the fully arcuate deflector assembly 1502 or thepartially arcuate deflector assembly 1602, the deflector assembly 1702is generally planar, concave, convex, saddle-shaped, or the like, and isconfigured to cover the ostium of the left vertebral artery 1724. Aninner member as described herein may be used with the protection device1700, for example extending through the deflector assembly 1702. Thedeflector assembly 1702 comprises a wire or strut 1704, which may becoupled to a deployment wire, deployment tube, etc., for example asdescribed herein with respect to filter assembly wires. The deflectorassembly 1702 may be collapsible into a compressed or delivery state atleast partially in the outer sheath 1706, for example as described withrespect to FIGS. 15A-15D. FIG. 17 illustrates a guidewire 1718 in theleft vertebral artery 1724. The guidewire 1718 may providecircumferential orientation of the deflector assembly 1702. For example,the deflector assembly 1702 may be advanced along the guidewire 1718such that the deflector assembly 1702 advances towards the leftvertebral artery 1724. The deflector assembly 1702 may have a lateraldiameter between about 3 mm and about 16 mm (e.g., about 3 mm, about 4mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm,about 16 mm, ranges between such values, and the like). Lengths largerthan about 16 mm are also possible, for example depending on anatomy ofa subject, location of placement, and the like. A deflector assembly1702 having a length greater than a diameter of an ostium of the leftvertebral artery (e.g., greater than about 6 mm) may provide easierplacement across the ostium of the left vertebral artery.

Combinations of filter assemblies and deflector assemblies providedherein are also possible. For example, the protection device maycomprise a filter assembly (e.g., the filter assembly 218, 406) and adeflector assembly (e.g., the deflector assembly 1402, 1502, 1602, 1702)proximal to the filter assembly, for example coupled to the samedeployment wire such that relative movement of the deployment wire andthe outer sheath can deploy both the filter assembly and the deflectorassembly. The filter assembly can filter blood proximate to the ostiumof the left subclavian artery and the deflector assembly can provide asecond layer of protection by deflecting any embolic material thatsomehow passes through the filter assembly or that forms downstream ofthe filter assembly from entering the left vertebral artery.

A possible advantage of the protection devices described herein may bethat the delivery and retrieval system are integrated into the samecatheter that stays in place during the procedure. Unloading and loadingof different catheters, sheaths, or other components is thereforeunnecessary. Having a system that performs both delivery and retrievalfunctions can reduce procedural complexity, time, and fluoroscopyexposure time. The device is not in the aortic arch, which can reduce oreliminate the chance of interference with other catheters.

While the methods and devices described herein may be susceptible tovarious modifications and alternative forms, specific examples thereofhave been shown in the drawings and are described in detail herein. Itshould be understood, however, that the inventive subject matter is notto be limited to the particular forms or methods disclosed, but, to thecontrary, covers all modifications, equivalents, and alternativesfalling within the spirit and scope of the various implementationsdescribed and the appended claims. Further, the disclosure herein of anyparticular feature, aspect, method, property, characteristic, quality,attribute, element, or the like in connection with an implementation orembodiment can be used in all other implementations or embodiments setforth herein. In any methods disclosed herein, the acts or operationscan be performed in any suitable sequence and are not necessarilylimited to any particular disclosed sequence and not be performed in theorder recited. Various operations can be described as multiple discreteoperations in turn, in a manner that can be helpful in understandingcertain embodiments; however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures described herein can be embodied asintegrated components or as separate components. For purposes ofcomparing various embodiments, certain aspects and advantages of theseembodiments are described. Not necessarily all such aspects oradvantages are achieved by any particular embodiment. Thus, for example,embodiments can be carried out in a manner that achieves or optimizesone advantage or group of advantages without necessarily achieving otheradvantages or groups of advantages. The methods disclosed herein mayinclude certain actions taken by a practitioner; however, the methodscan also include any third-party instruction of those actions, eitherexpressly or by implication. For example, actions such as “deploying aself-expanding filter” include “instructing deployment of aself-expanding filter.” The ranges disclosed herein also encompass anyand all overlap, sub-ranges, and combinations thereof. Language such as“up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“about” or “approximately” include the recited numbers and should beinterpreted based on the circumstances (e.g., as accurate as reasonablypossible under the circumstances, for example ±5%, ±10%, ±15%, etc.).For example, “about 7 mm” includes “7 mm.” Phrases preceded by a termsuch as “substantially” include the recited phrase and should beinterpreted based on the circumstances (e.g., as much as reasonablypossible under the circumstances). For example, “substantially straight”includes “straight.”

What is claimed is:
 1. An embolic material protection device configuredto inhibit embolic material from entering cerebral vasculature through aleft vertebral artery, the device comprising: an outer sheath; an innermember radially inward of the outer sheath, the inner member comprisinga guidewire lumen, the inner member trackable over a guidewire; and aself-expanding filter assembly radially between the outer sheath and theinner member, the self-expanding filter assembly being deployable out ofthe outer sheath by at least one of proximally retracting the outersheath and distally advancing the self-expanding filter assembly, theself-expanding filter assembly comprising: a frame; and a filter elementcoupled to the frame, the inner member longitudinally movableindependent of the self-expanding filter assembly and the outer sheath,wherein the self-expanding filter assembly further comprises: a filterwire; a guide tube proximal to the filter element, the guide tubecoupled to the frame; and a barrel proximal to the guide tube, thebarrel coupled to the filter wire and the frame.
 2. The device of claim1, wherein the self-expanding filter assembly comprises: a filter wire;and a crimp tube, the crimp tube coupled to the filter wire by a firstcrimp, the crimp tube coupled to the frame by a second crimplongitudinally offset from the first crimp.
 3. The device of claim 1,wherein the self-expanding filter assembly comprises: a filter wire; anda guide tube coupled to the filter wire and the frame, the guide tubecomprising a chamfered proximal end.
 4. The device of claim 1, whereinthe self-expanding filter assembly comprises: a deployment tube; abarrel coupled to the deployment tube; and a radiopaque ring, the barrelcoupled the frame by the radiopaque ring.
 5. The device of claim 1,wherein the self-expanding filter assembly comprises: a deployment tube;a radiopaque ring coupled to the deployment tube; and the frame.
 6. Thedevice of claim 1, wherein the self-expanding filter assembly isconfigured to be distal-facing.
 7. The device of claim 1, wherein theself-expanding filter assembly is configured to be proximal-facing. 8.The device of claim 1, wherein the inner member comprises an atraumaticdistal tip.
 9. The device of claim 1, further comprising an arterialpressure monitoring device in fluid communication with one of a lumen ofthe outer sheath and the guidewire lumen of the inner member.
 10. A kitcomprising: the device of claim 1; and a filtering device configured tobe positioned in an innominate artery and a left common carotid artery.11. An embolic material protection device configured to inhibit embolicmaterial from entering cerebral vasculature through a left vertebralartery, the device comprising: an outer sheath; an inner member radiallyinward of the outer sheath, the inner member comprising a lumen; and afilter assembly radially between the outer sheath and the inner member,the filter assembly being deployable out of the outer sheath, the filterassembly comprising: a frame; and a filter element coupled to the frame,the inner member longitudinally movable independent of the filterassembly and the outer sheath, wherein the filter assembly furthercomprises: a filter wire; a guide tube proximal to the filter element,the guide tube coupled to the frame; and a barrel proximal to the guidetube, the barrel coupled to the filter wire and the frame.
 12. Thedevice of claim 11, wherein the filter assembly comprises: a filterwire; and a coupling structure coupled to the filter wire and the frame.13. The device of claim 12, wherein the coupling structure comprises achamfered proximal end.
 14. The device of claim 11, wherein the filterassembly comprises: a deployment tube; a coupling structure coupled tothe deployment tube; and the frame.
 15. The device of claim 11, whereinthe filter assembly is configured to be distal-facing.
 16. The device ofclaim 11, wherein the filter assembly is configured to beproximal-facing.
 17. The device of claim 11, wherein the inner membercomprises an atraumatic distal tip.
 18. The device of claim 11, furthercomprising an arterial pressure monitoring device in fluid communicationwith one of a lumen of the outer sheath and a guidewire lumen of theinner member.
 19. A kit comprising: the device of claim 11; and afiltering device configured to be positioned in an innominate artery anda left common carotid artery.